Autoinjector

ABSTRACT

An autoinjector includes a case having a rib, a needle shroud telescopically coupled to the case, a carrier slidably arranged in the case and adapted to hold a medicament container, and a collar rotatably and slidably disposed in the case and coupled to the needle shroud and the carrier. The needle shroud is movable between a first extended position, a retracted position and a locked second extended position. The carrier is movable from a first axial position to a second axial position relative to the case. The collar abuts the rib when the needle shroud is in the first extended position and the carrier is in the first axial position, and the collar disengages the rib when the needle shroud is in the retracted position and the carrier is in the second axial position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/903,351, filed Jan. 7, 2016, which is a U.S. national stageapplication under 35 USC § 371 of International Application No.PCT/EP2014/064425, filed on Jul. 7, 2014, which claims priority toEuropean Patent Application No. 13175662.9, filed on Jul. 9, 2013, theentire contents of which are incorporated herein by reference.

TECHNICAL FIELD

The invention relates to an autoinjector.

BACKGROUND

Administering an injection is a process which presents a number of risksand challenges for users and healthcare professionals, both mental andphysical. Injection devices typically fall into two categories—manualdevices and autoinjectors. In a conventional manual device, manual forceis required to drive a medicament through a needle. This is typicallydone by some form of button/plunger that has to be continuously pressedduring the injection. There are numerous disadvantages associated withthis approach. For example, if the button/plunger is releasedprematurely, the injection will stop and may not deliver an intendeddose. Further, the force required to push the button/plunger may be toohigh (e.g., if the user is elderly or a child). And, aligning theinjection device, administering the injection and keeping the injectiondevice still during the injection may require dexterity which somepatients (e.g., elderly patients, children, arthritic patients, etc.)may not have.

Autoinjector devices aim to make self-injection easier for patients. Aconventional autoinjector may provide the force for administering theinjection by a spring, and trigger button or other mechanism may be usedto activate the injection. Autoinjectors may be single-use or reusabledevices.

There remains a need for an improved autoinjector.

SUMMARY

It is an object of the present invention to provide an improvedautoinjector.

In an exemplary embodiment, an autoinjector according to the presentinvention comprises a case having a rib, a needle shroud telescopicallycoupled to the case and movable between a first extended position, aretracted position and a locked second extended position, a carrierslidably arranged in the case, adapted to hold a medicament container,and movable from a first axial position to a second axial positionrelative to the case, and a collar rotatably and slidably disposed inthe case and coupled to the needle shroud and the carrier. The collarabuts the rib when the needle shroud is in the first extended positionand the carrier is in the first axial position, and the collardisengages the rib when the needle shroud is in the retracted positionand the carrier is in the second axial position.

In an exemplary embodiment, the autoinjector further comprises a plungerslidably coupled to the carrier, and a drive spring biasing the plungerrelative to the carrier. The carrier includes a compliant beam having aboss adapted to engage an opening in the plunger when the carrier is inthe first axial position. The boss is adapted to engage the case whenthe carrier is in the second axial position.

In an exemplary embodiment, the collar includes a shroud boss adapted toengage a shroud slot in the needle shroud, a carrier boss adapted toengage a carrier slot in the carrier and a case boss adapted to engagethe rib in the case. The shroud boss, the carrier boss and the case bossare disposed in approximately a same plane on the collar.

In an exemplary embodiment, the collar is in a first angular positionrelative to the case when the needle shroud is in the first extendedposition and the carrier is in the first axial position. The collarrotates to a second angular position relative to the case and translatesproximally relative to the case when the needle shroud moves from thefirst extended position to the retracted position. The collar translatesdistally relative to the case when the needle shroud is in the retractedposition and the carrier moves from the first axial position to thesecond axial position. The boss disengages the opening when the carrieris in the second axial position and wherein the plunger translatesaxially relative to the carrier under the force of the drive springadvancing the carrier from the second axial position to a third axialposition relative to the case. The collar rotates to a third angularposition relative to the case and translates with the needle shrouddistally relative to the case when the carrier is in the third axialposition. The collar rotates to a fourth angular position relative tothe case when the needle shroud is in the locked second extendedposition. The shroud boss engages a shroud slot notch in the shroud slotand the carrier boss engages a carrier slot notch in the carrier slotwhen the collar is in the fourth angular position and the needle shroudis in the locked second extended position. The engagement of the carrierboss and the carrier slot notch substantially fixes the collar in anaxial position relative to the case.

In an exemplary embodiment, the autoinjector further comprises a controlspring biasing the collar relative to the case.

In an exemplary embodiment, the autoinjector further comprises a triggerbutton coupled to or integral with the carrier.

Further scope of applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description given hereinbelow and the accompanying drawingswhich are given by way of illustration only, and thus, are not limitiveof the present invention, and wherein:

FIG. 1A is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention prior to use,

FIG. 1B is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention prior to use,

FIG. 1C is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention prior to use,

FIG. 1D is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention prior to use,

FIG. 1E is a semi-transparent side view of an exemplary embodiment of anautoinjector according to the present invention prior to use,

FIG. 1F is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention prior to use,

FIG. 1G is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention prior to use,

FIGS. 2A to 21 are schematic views of an exemplary embodiment of acontrol mechanism for an autoinjector according to the presentinvention,

FIG. 3A is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 3B is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 3C is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 3D is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 3E is a semi-transparent side view of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 3F is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 3G is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 4A is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 4B is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 4C is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 4D is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 4E is a semi-transparent side view of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 4F is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 4G is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 5A is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 5B is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 5C is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 5D is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use larity,

FIG. 5E is a semi-transparent side view of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 5F is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 5G is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 6A is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 6B is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 6C is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 6D is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention during use,

FIG. 6E is a semi-transparent side view of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 6F is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 6G is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention during use,

FIG. 7A is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention after use,

FIG. 7B is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention after use,

FIG. 7C is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention after use,

FIG. 7D is a side view of an exemplary embodiment of an autoinjectoraccording to the present invention after use,

FIG. 7E is a semi-transparent side view of an exemplary embodiment of anautoinjector according to the present invention after use,

FIG. 7F is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention after use, and

FIG. 7G is a longitudinal section of an exemplary embodiment of anautoinjector according to the present invention after use.

Corresponding parts are marked with the same reference symbols in allfigures.

DETAILED DESCRIPTION

FIGS. 1A-1F and 1B are different views of an exemplary embodiment of anautoinjector 1 according to the present invention prior to use. In anexemplary embodiment, the autoinjector 1 includes a case 2telescopically coupled to a needle shroud 7. FIGS. 1C and 1D are relatedside views of the autoinjector 1 with the case 2 removed for clarity.FIG. 1E is a related semi-transparent side view of the case 2. FIGS. 1Fand 1G are related longitudinal sections of the autoinjector 1.

In an exemplary embodiment as shown in FIGS. 1F and 1G, the case 2 isadapted to receive a medicament container, such as a syringe 3containing a medicament M. The syringe 3 may be a pre-filled syringe andhave a needle 4 arranged at a distal end. When the autoinjector 1 or thesyringe 3 is assembled, a protective needle sheath 5 is removablyattached to the needle 4. A stopper 6 is arranged for sealing thesyringe 3 proximally and for displacing the medicament M contained inthe syringe 3 through the needle 4. In other exemplary embodiments, themedicament container may be a cartridge or an ampoule, and the needle 4may be removably coupled to the medicament container. In an exemplaryembodiment, the syringe 3 is held in a syringe carrier 8 and supportedat its proximal end therein. The syringe carrier 8 is slidably arrangedwithin the case 2.

In an exemplary embodiment, a cap (not illustrated) may be removablycoupled to a distal end of the case 2. The case 2 may include a viewingwindow 2.7 for providing visual access to contents of the syringe 3.

In an exemplary embodiment, the needle shroud 7 is telescoped in thedistal end of the case 2. A control spring 9 is arranged to bias theneedle shroud 7 in a distal direction D relative to the case 2.

In an exemplary embodiment, a drive spring 10 (which may be acompression spring) is arranged within a proximal part 8.1 of thesyringe carrier 8. A plunger 12 serves for forwarding a force of thedrive spring 10 to the stopper 6. In an exemplary embodiment, theplunger 12 is hollow and telescoped within the proximal part 8.1 of thesyringe carrier 8 wherein the drive spring 10 is arranged within theplunger 12 biasing the plunger 12 in the distal direction D relative tothe syringe carrier 8. In an exemplary embodiment, the proximal part 8.1of the syringe carrier 8 protrudes through an opening in a proximal endof the case 2 and serves as a trigger button 13. In other exemplaryembodiments, a button overmold may be coupled to or integralled formedwith the trigger button 13.

In an exemplary embodiment, a plunger release mechanism 15 is arrangedfor preventing release of the plunger 12 prior to the needle 4 reachingan insertion depth and for releasing the plunger 12 once the needle 4reaches its insertion depth. The plunger release mechanism 15 maycomprise one or more compliant beams 8.3 with a respective first boss8.4 arranged on the syringe carrier 8, a respective first opening 12.1(best seen in FIG. 5F) laterally arranged in the plunger 12 for engagingthe first boss 8.4, a proximal narrow section 2.4 of the case 2 adaptedto radially outwardly support the first boss 8.4 and prevent it fromdisengaging the first opening 12.1, a wide section 2.5 in the case 2distal of the narrow section 2.4 adapted to allow radially outwarddeflection of the first boss 8.4 once the first boss 8.4 is axiallyaligned with the wide section 2.5. At least one of the first boss 8.4and the first opening 12.1 may be ramped such that the plunger 12 underload from the drive spring 10 deflects the first boss 8.4 radiallyoutwards.

In an exemplary embodiment, a control mechanism 21 (best seen in FIGS.2A to 21) is arranged for selectively applying the force of the controlspring 9 to the syringe carrier 8 or to the needle shroud 7.Furthermore, the control mechanism 21 is arranged for locking thetrigger button 13 such that it cannot be operated prior to depression ofthe needle shroud 7 against an injection site and for unlocking thetrigger button 13 on depression of the needle shroud 7 against theinjection site, thus allowing operation of the trigger button 13.

In an exemplary embodiment, the control mechanism 21 comprises a collar16 having a shroud boss 18 adapted to engage a shroud slot 17 in theneedle shroud 7, a carrier boss 20 adapted to engage a carrier slot 19in the syringe carrier 8, and a case boss 22 adapted to engage an angledcase rib 2.9 on the case 2.

In an exemplary embodiment, the control spring 9 is proximally groundedin the case 2 and distally bears against the collar 16 which is movableaxially and rotationally relative to the case 2. In the initial stateprior to use, the control spring 9 may be compressed between the case 2and the collar 16.

FIGS. 2A to 21 are schematic views of exemplary embodiments of thecomponents of the control mechanism 21 corresponding to different statesof operation of the autoinjector 1. Although the case boss 22, thecarrier boss 20 and the shroud boss 18 are shown at different axialpositions for clarity in FIGS. 2A to 21, in an exemplary embodiment, allof the bosses 18, 20, 22 on the collar 16 are disposed in the same planeas shown in FIG. 1E. In an exemplary embodiment, the shroud slot 17comprises a transversal first surface 17.1, a transversal second surface17.2, a longitudinal third surface 17.3, a transversal fourth surface17.4, an angled fifth surface 17.5, a transversal sixth surface 17.6 anda transversal seventh surface 17.7. In an exemplary embodiment, thecarrier slot 19 comprises a transversal first surface 19.1, an angledsecond surface 19.2, an angled third surface 19.3, a longitudinal fourthsurface 19.4 and a transversal fifth surface 19.5.

A exemplary sequence of operation of the autoinjector 1 is as follows:

Prior to use the autoinjector 1 is in the state as illustrated in FIGS.1A to 1G, and the control mechanism 21 is in the state illustrated inFIG. 2A. If applicable, the autoinjector 1 is removed from a packaging.The medicament M in the syringe 3 may be visually examined through theviewing window 2.7.

If the cap (not illustrated) is attached to the case 2 and/or theprotective needle sheath 5, the cap may be removed by pulling it in thedistal direction D away from the case 2 thereby also removing theprotective needle sheath 5 from the needle 4. The load exerted bypulling the cap 11 is resolved in the case 2, because the case boss 22on the collar 16 abuts the angled case rib 2.9 in the distal directionD. The collar 16 is in a first angular position relative to the case 2.As the case rib 2.9 is angled, a rotational force in a first rotationaldirection R1 and an axial force in the distal direction Dare applied tothe collar 16 due to the control spring 9 biasing the collar 16 in thedistal direction D. The rotational and axial forces are resolved by theshroud boss 18 abutting the shroud slot 17 and/or the carrier boss 20abutting the carrier slot 19 (in the illustrated embodiment both areused) such that the collar 16 cannot rotate or translate axiallyrelative to the case 2. The syringe carrier 8 is in a first axialposition relative to the case 2.

Movement of the syringe carrier 8 in the distal direction D is preventedby the carrier boss 20 being in contact with the angled second surface19.2 of the carrier slot 19. Thus, depression of the trigger button 13is prevented. Movement of the syringe carrier 8 in the proximaldirection P is prevented by a backstop (not illustrated) on the case 2.Furthermore, the force of the control spring 9 on the collar 16 preventsthe syringe carrier 8 from moving in the proximal direction P.

The needle shroud 7 is in a first extended position EP, protruding fromthe case 2 in the distal direction D. The extension of the needle shroud7 distally beyond the case 2 is limited by the shroud boss 18 abuttingthe transversal first surface 17.1 and the transversal second surface17.2 on the shroud slot 17. Due to the collar 16 being prevented frommoving in the distal direction D by the case rib 2.9, the needle shroud7 cannot move in the distal direction D either. Movement of the needleshroud 7 in the proximal direction P relative to the case 2 results in acorresponding axial translation of the collar 16 relative to the case 2,compressing the control spring 9.

The plunger release mechanism 15 prevents the plunger 12 from beingreleased.

When the autoinjector 1 is pressed against an injection site, the needleshroud 7 is pressed into the case 2 into a retracted position RP againstthe force of the control spring 9.

FIGS. 3A and 3B are different views of an exemplary embodiment of theautoinjector 1 with the needle shroud 7 in the retracted position RP.FIGS. 3C and 3D are related side views of the autoinjector 1 with thecase 2 removed for clarity. FIG. 3E is a related semi-transparent sideview of the case 2 with the collar 16. FIGS. 3F and 3G are relatedlongitudinal sections of the autoinjector 1. FIG. 2B shows the controlmechanism 21 as the needle shroud 7 is translating from the extendedposition EP to the retracted position RP. FIG. 2C shows the controlmechanism 21 when the needle shroud 7 is in the retracted position RP.

The force opposing depression of the needle shroud 7 is provided by thecontrol spring 9 through the collar 16 and the shroud boss 18 engagingthe transversal first surface 17.1. During depression of the needleshroud 7 towards the retracted position RP, the shroud boss 18 abuts thetransversal first surface 17.1 of the shroud slot 17 (cf. FIG. 2B)causing the collar 16 to translate axially in the proximal direction Prelative to the case 2. The carrier boss 20 disengages the transversalfirst surface 19.1 of the carrier slot 19 in the proximal direction P.As the angled second surface 19.2 of the carrier slot 19 is angledrelative to a transverse axis of the case 2, a rotational force isapplied to the collar 16 in a second rotational direction R2 oppositethe first rotational direction R1, causing the collar 16 to rotate to asecond angular position relative to the case 2. If the autoinjector 1were removed from the injection site, the collar 16 and needle shroud 7would return in the distal direction D into the positions shown in FIGS.1A to 1G and the control mechanism 21 would return into the state shownin FIG. 2A due to the engagement of the case boss 22 to the angled caserib 2.9 applying the rotational force to the collar 16 in the firstrotational direction R1.

When the needle shroud 7 is in the retracted position RP, the case boss22 remains abutting the case rib 2.9 (cf. FIG. 3E) and the shroud boss18 remains abutting the transversal first surface 17.1 of the shroudslot 17 (cf. FIG. 3C). Thus, the collar 16 is prevented from movingaxially relative to the case 2.

FIGS. 4A and 4B are different side views of an exemplary embodiment ofthe autoinjector 1 after depression of the trigger button 13. FIGS. 4Cand 4D are related side views of the autoinjector 1 with the case 2removed for clarity. FIG. 4E is a related semi-transparent side view ofthe case 2 with the collar 16. FIGS. 4F and 4G are related longitudinalsections of the autoinjector 1.

When the trigger button 13 is pressed, the syringe carrier 8 moves inthe distal direction D from the first axial position to a second axialposition relative to the case 2, causing the carrier boss 20 to ridefurther along the angled second surface 19.2 and thereby rotating thecollar 16 relative to the case 2 in the second rotational direction R2to a third angular position relative to the case 2. After sufficientrotation of the collar 16 relative to the case 2, the shroud boss 18comes clear of the transversal first surface 17.1 of the shroud slot 17,and the case boss 22 comes clear of the case rib 2.9. As the collar 16is thus axially neither supported by the case 2 nor by the shroud slot17, the collar 16 moves in the distal direction D guided by the shroudboss 18 along the longitudinal third surface 17.3 (cf. FIG. 2D), whereinthe carrier boss 20 disengages the angled second surface 19.2 and movesin the distal direction D towards the angled third surface 19.3 of thecarrier slot 19. As the carrier boss 20 engages the angled third surface19.3 of the carrier slot 19, a rotational force in the second rotationaldirection R2 is applied to the collar 16 which is resolved by the shroudboss 18 abutting the third longitudinal surface 17.3 such that thecarrier boss 20 cannot disengage the angled third surface 19.3. Thecollar 16 and the control spring 9 are thus axially coupled to thesyringe carrier 8. The control spring 9 coupled to the syringe carrier 8through the collar 16 advances the syringe carrier 8 from the secondaxial position to a third axial position in the distal direction Drelative to the case 2 such that the needle 4 is extended from the case2 and inserted into the injection site.

FIGS. 5A and 5B are different side views of an exemplary embodiment ofthe autoinjector 1 with the needle 4 extending from the case 2. FIGS. 5Cand 5D are related side views of the autoinjector 1 with the case 2removed for clarity. FIG. 5E is a related semi-transparent side view ofthe case 2 with the collar 16. FIGS. 5F and 5G are related longitudinalsections of the autoinjector 1.

The translation of the syringe carrier 8 relative to the case 2 islimited when the shroud boss 18 abuts the transversal fourth surface17.4 of the shroud slot 17 (cf. FIG. 2F). The transversal fourth surface17.4 thus defines a penetration depth of the needle 4.

In an exemplary embodiment, prior to the shroud boss 18 abutting thetransversal fourth surface 17.4 of the shroud slot 17, the plunger 12 isreleased by the plunger release mechanism 15. As the syringe carrier 8translates in the distal direction D relative to the case 2, thecompliant beams 8.3 reach the wide section 2.5, and the plunger 12,under load from the drive spring 10, deflects the first boss 8.4 on thecompliant beam 8.3 radially outwards such that the first boss 8.4disengages the first opening 12.1 in the plunger 12. The plunger 12 isthus released and advanced by the drive spring 10 displacing the stopper6 within the syringe 3 and ejecting the medicament M through the needle4. The release of the plunger release mechanism 15 may provide anaudible and/or tactile feedback to the user. The progress of delivery ofthe medicament M can be observed through the viewing window 2.7 byexamining the movement of the plunger 12 within the syringe 3. Theplunger 12 is visible in the viewing window 2.7 thus helping the userdifferentiate between a used and an un-used autoinjector 1.

If the autoinjector 1 is removed from the injection site at any timeafter the needle 4 has reached insertion depth, the needle shroud 7moves in the distal direction D driven by the control spring 9 which iscoupled to the needle shroud 7 through the collar 16 and the shroud boss18 abutting the transversal fourth surface 17.4 of the shroud slot 17.

FIGS. 6A and 6B are different side views of an exemplary embodiment ofthe autoinjector 1 with the syringe 3 emptied. FIGS. 6C and 6D arerelated side views of the autoinjector 1 with the case 2 removed forclarity. FIG. 6E is a related semi-transparent side view of the case 2with the collar 16. FIGS. 6F and 6G are related longitudinal sections ofthe autoinjector 1.

When the syringe carrier 8 abuts a front stop (not illustrated) on thecase 2, the shroud boss 18 disengages the longitudinal third surface17.3 and abuts the transversal fourth surface 14. The force of thecontrol spring 9 causes the collar 16 to translate axially and ridealong the angled third surface 19.3. Because the shroud boss 18 does notabut the longitudinal third surface, the collar 16 rotates relative tothe case 2 in the second rotational direction R2 to a fourth angularposition relative to the case 2 due to the angled third surface 19.3.After sufficient rotation of the collar 16 in the second rotationaldirection R2, the carrier boss 20 disengages the angled third surface19.3, and the shroud boss 18 moves from contact with the transversalfourth surface 17.4 to the angled fifth surface 17.5 (cf. FIG. 2G).After further rotation of the collar 16 in the second rotationaldirection R2, the carrier boss 20 abuts the longitudinal fourth surface19.4, preventing further rotation of the collar 16 in the secondrotational direction R2 but allowing for axial translation of the collar16. The shroud boss 18 applies an axial force on the angled fifthsurface 17.5 to push the needle shroud 7 in the distal direction Drelative to the case 2. When the carrier boss 20 disengages thelongitudinal fourth surface 19.4, the force of the control spring 9causes the collar 16 to rotate in the second rotational direction R2,because the shroud boss 18 abuts the angled fifth surface 17.5 of theshroud slot 17.

The collar 16 rotates as the shroud boss 18 moves along the angled fifthsurface 17.5 from the position shown in FIG. 2H until it abuts thetransversal sixth surface 17.6, and the rotation results in the carrierboss 20 engaging a notch adjacent a transversal fifth surface 19.5 inthe carrier slot 19 (cf. FIG. 21). At this point, the needle shroud 7may abut a front stop (not illustrated) in the case 2. The needle shroud7 is now in a second extended position SEP extending further from thecase 2 in the distal direction D than in the extended position EP thushiding the extended needle 4. If the needle shroud 7 is attempted tomove proximally from the second extended position SEP, the collar 16 issubstantially prevented from moving axially relative to the case 2,which prevents the needle shroud 7 from moving proximally relative tothe case 2 from the second extended position SEP. The syringe carrier 8has locked in an axial position relative to the case 2 (see FIG. 5F inwhich the first boss 8.4 proximally abuts the narrow section 2.4 of thecase 2), and the collar 16 is substantially axially locked relative tothe syringe carrier 8 via the engagement of the carrier boss 20 in thenotch. If the needle shroud 7 is depressed, the shroud boss 18 will abutthe sixth transversal surface 17.6 and prevent the needle shroud 7 fromretracting. Thus, the needle shroud 7 is prevented from being retractedand is locked in the second extended position SEP to cover the needle 4.This action is activated as soon as the needle 4 reaches insertiondepth, and hence the needle 4 will always be shrouded upon removal fromthe injection site. This reduces the risk of needle stick injury.

FIGS. 7A and 7B are different side views of an exemplary embodiment ofthe autoinjector 1 removed from the injection site with the needleshroud 7 in the second extended position SEP. FIGS. 7C and 7D arerelated side views of the autoinjector 1 with the case 2 removed forclarity. FIG. 7E is a related semi-transparent side view of the case 2with the collar 16. FIGS. 7F and 7G are related longitudinal sections ofthe autoinjector 1.

In an exemplary embodiment, the shroud boss 18 could be arranged on theneedle shroud 7 and engaged in the shroud slot 17, which would bearranged in the collar 16. Likewise the carrier boss 20 could bearranged on the syringe carrier 8 and engaged in the carrier slot 19,which would be arranged in the collar 16. Likewise the angled case rib2.9 could be arranged on the collar 16 and the case boss 22 on the case2.

In another exemplary embodiment, the control mechanism 21 could beadapted to be applied in an autoinjector 1 without the trigger button13, but which is activated based on depression of the needle shroud 7.For example, the a modified control mechanism 21 could include, e.g. asteeper angle of the angled second surface 19.2 of the carrier slot 19,a reduced length of the transversal first surface 17.1 of the shroudslot 17, and/or a reduced length of the angled case rib 2.9.

In an exemplary embodiment, the case 2 may comprise a front case and arear case which are attached to form the case 2, in order to facilitateassembly.

The term “drug” or “medicament”, as used herein, means a pharmaceuticalformulation containing at least one pharmaceutically active compound,

-   wherein in one embodiment the pharmaceutically active compound has a    molecular weight up to 1500 Da and/or is a peptide, a proteine, a    polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or a    fragment thereof, a hormone or an oligonucleotide, or a mixture of    the above-mentioned pharmaceutically active compound,-   wherein in a further embodiment the pharmaceutically active compound    is useful for the treatment and/or prophylaxis of diabetes mellitus    or complications associated with diabetes mellitus such as diabetic    retinopathy, thromboembolism disorders such as deep vein or    pulmonary thromboembolism, acute coronary syndrome (ACS), angina,    myocardial infarction, cancer, macular degeneration, inflammation,    hay fever, atherosclerosis and/or rheumatoid arthritis,-   wherein in a further embodiment the pharmaceutically active compound    comprises at least one peptide for the treatment and/or prophylaxis    of diabetes mellitus or complications associated with diabetes    mellitus such as diabetic retinopathy,-   wherein in a further embodiment the pharmaceutically active compound    comprises at least one human insulin or a human insulin analogue or    derivative, glucagon-like peptide (GLP-1) or an analogue or    derivative thereof, or exendin-3 or exendin-4 or an analogue or    derivative of exendin-3 or exendin-4.

Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) humaninsulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) humaninsulin; Asp(B28) human insulin; human insulin, wherein praline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) humaninsulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl humaninsulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N—(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyheptadecanoyl) human insulin.

Exendin-4 for example means Exendin-4(1-39), a peptide of the sequenceH-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following listof compounds:

-   H-(Lys)4-des Pro36, des Pro37Exendin-4(1-39)-NH2, H-(Lys)5-des    Pro36, des Pro37Exendin-4(1-39)-NH2, des Pro36 Exendin-4(1-39), des    Pro36 [Asp28] Exendin-4(1-39), des Pro36 [IsoAsp28] Exendin-4(1-39),    des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), des Pro36 [Met(O)14,    IsoAsp28] Exendin-4(1-39), des Pro36 [Trp(O2)25, Asp28]    Exendin-4(1-39), des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),    des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39), des Pro36    [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or-   des Pro36 [Asp28] Exendin-4(1-39), des Pro36 [IsoAsp28]    Exendin-4(1-39), des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), des    Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39), des Pro36 [Trp(O2)25,    Asp28] Exendin-4(1-39), des Pro36 [Trp(O2)25, IsoAsp28]    Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, Asp28]    Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28]    Exendin-4(1-39),-   wherein the group -Lys6-NH2 may be bound to the C-terminus of the    Exendin-4 derivative;-   or an Exendin-4 derivative of the sequence des Pro36    Exendin-4(1-39)-Lys6-NH2 (AVE0010), H-(Lys)6-des Pro36 [Asp28]    Exendin-4(1-39)-Lys6-NH2, des Asp28 Pro36, Pro37,    Pro38Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro38 [Asp28]    Exendin-4(1-39)-NH2, H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28]    Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Asp28]    Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28]    Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38    [Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Trp(O2)25,    Asp28] Exendin-4(1-39)-Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38    [Trp(O2)25] Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38    [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36,    Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, des Pro36,    Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,    H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38    [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36    [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2, des Met(O)14 Asp28    Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2, H-(Lys)6-desPro36, Pro37,    Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36,    Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, des Pro36,    Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,    H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38    [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Lys6-des Pro36    [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, H-des Asp28    Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] Exendin-4(1-39)-NH2,    H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14,    Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38    [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,    H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(S1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38    [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2;-   or a pharmaceutically acceptable salt or solvate of any one of the    afore-mentioned Exendin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones orregulatory active peptides and their antagonists as listed in RoteListe, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin,Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin),Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid,a heparin, a low molecular weight heparin or an ultra low molecularweight heparin or a derivative thereof, or a sulphated, e.g. apoly-sulphated form of the above-mentioned polysaccharides, and/or apharmaceutically acceptable salt thereof. An example of apharmaceutically acceptable salt of a poly-sulphated low molecularweight heparin is enoxaparin sodium.

Antibodies are globular plasma proteins (˜150 kDa) that are also knownas immunoglobulins which share a basic structure. As they have sugarchains added to amino acid residues, they are glycoproteins. The basicfunctional unit of each antibody is an immunoglobulin (Ig) monomer(containing only one Ig unit); secreted antibodies can also be dimericwith two Ig units as with IgA, tetrameric with four Ig units liketeleost fish IgM, or pentameric with five Ig units, like mammalian IgM.

The Ig monomer is a “Y”-shaped molecule that consists of fourpolypeptide chains; two identical heavy chains and two identical lightchains connected by disulfide bonds between cysteine residues. Eachheavy chain is about 440 amino acids long; each light chain is about 220amino acids long. Heavy and light chains each contain intrachaindisulfide bonds which stabilize their folding. Each chain is composed ofstructural domains called Ig domains. These domains contain about 70-110amino acids and are classified into different categories (for example,variable or V, and constant or C) according to their size and function.They have a characteristic immunoglobulin fold in which two 13 sheetscreate a “sandwich” shape, held together by interactions betweenconserved cysteines and other charged amino acids.

There are five types of mammalian Ig heavy chain denoted by a, o, £, y,and μ. The type of heavy chain present defines the isotype of antibody;these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies,respectively.

Distinct heavy chains differ in size and composition; a and y containapproximately 450 amino acids and O approximately 500 amino acids, whileμ and £ have approximately 550 amino acids. Each heavy chain has tworegions, the constant region (CH) and the variable region (VH)— In onespecies, the constant region is essentially identical in all antibodiesof the same isotype, but differs in antibodies of different isotypes.Heavy chains y, a and o have a constant region composed of three tandemIg domains, and a hinge region for added flexibility; heavy chains μ and£ have a constant region composed of four immunoglobulin domains. Thevariable region of the heavy chain differs in antibodies produced bydifferent B cells, but is the same for all antibodies produced by asingle B cell or B cell clone. The variable region of each heavy chainis approximately 110 amino acids long and is composed of a single Igdomain.

In mammals, there are two types of immunoglobulin light chain denoted by′A and K. A light chain has two successive domains: one constant domain(CL) and one variable domain (VL). The approximate length of a lightchain is 211 to 217 amino acids. Each antibody contains two light chainsthat are always identical; only one type of light chain, Kor ′A, ispresent per antibody in mammals.

Although the general structure of all antibodies is very similar, theunique property of a given antibody is determined by the variable (V)regions, as detailed above. More specifically, variable loops, threeeach the light (VL) and three on the heavy (VH) chain, are responsiblefor binding to the antigen, i.e. for its antigen specificity. Theseloops are referred to as the Complementarity Determining Regions (CDRs).Because CDRs from both VH and VL domains contribute to theantigen-binding site, it is the combination of the heavy and the lightchains, and not either alone, that determines the final antigenspecificity.

An “antibody fragment” contains at least one antigen binding fragment asdefined above, and exhibits essentially the same function andspecificity as the complete antibody of which the fragment is derivedfrom. Limited proteolytic digestion with papain cleaves the Ig prototypeinto three fragments. Two identical amino terminal fragments, eachcontaining one entire L chain and about half an H chain, are the antigenbinding fragments (Fab). The third fragment, similar in size butcontaining the carboxyl terminal half of both heavy chains with theirinterchain disulfide bond, is the crystalizable fragment (Fe). The Fecontains carbohydrates, complement-binding, and FcR-binding sites.Limited pepsin digestion yields a single F(ab′)2 fragment containingboth Fab pieces and the hinge region, including the H—H interchaindisulfide bond. F(ab′)2 is divalent for antigen binding. The disulfidebond of F(ab′)2 may be cleaved in order to obtain Fab′. Moreover, thevariable regions of the heavy and light chains can be fused together toform a single chain variable fragment (scFv).

Pharmaceutically acceptable salts are for example acid addition saltsand basic salts. Acid addition salts are e.g. HCl or HBr salts. Basicsalts are e.g. salts having a cation selected from alkali or alkaline,e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), whereinR1 to R4 independently of each other mean: hydrogen, an optionallysubstituted C1-06-alkyl group, an optionally substituted C2-C6-alkenylgroup, an optionally substituted C6-C10-aryl group, or an optionallysubstituted C6-C10-heteroaryl group. Further examples ofpharmaceutically acceptable salts are described in “Remington'sPharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), MarkPublishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia ofPharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates.

Those of skill in the art will understand that modifications (additionsand/or removals) of various components of the apparatuses, methodsand/or systems and embodiments described herein may be made withoutdeparting from the full scope and spirit of the present invention, whichencompass such modifications and any and all equivalents thereof.

1-14. (canceled)
 15. An autoinjector comprising: a case having a rib; aneedle shroud telescopically coupled to the case and movable between afirst extended position, a retracted position and a locked secondextended position; a carrier arranged in the case and adapted to hold amedicament container, a plunger slidably coupled to the carrier; a drivespring biasing the plunger relative to the carrier, the plunger movablefrom a first axial position to a second axial position relative to thecase; and a collar slidably disposed in the case, the collar coupled tothe needle shroud, wherein the plunger abuts the rib when the needleshroud is in the first extended position, and the plunger disengages therib when the needle shroud is in the retracted position.
 16. Theautoinjector according to claim 15 wherein the collar includes a shroudboss adapted to engage a plunger boss on the plunger and a case bossadapted to engage the rib of the case.
 17. The autoinjector according toclaim 16, wherein the shroud boss, a carrier boss and the case boss aredisposed in approximately a same plane on the collar.
 18. Theautoinjector according to claim 15, wherein the carrier includes acompliant beam having a boss adapted to engage an opening in the plungerwhen the carrier is in a first axial position.
 19. The autoinjectoraccording to claim 18, wherein the boss is adapted to engage the casewhen the carrier is in a second axial position.
 20. The autoinjectoraccording to claim 15, wherein the collar is in a first angular positionrelative to the case when the needle shroud is in the first extendedposition and the carrier is in the first axial position.
 21. Theautoinjector according to claim 20, wherein the collar rotates to asecond angular position relative to the case and translates proximallyrelative to the case when the needle shroud moves from the firstextended position to the retracted position.
 22. The autoinjectoraccording to claim 21, wherein the collar translates distally relativeto the case when the needle shroud is in the retracted position and thecarrier moves from the first axial position to a second axial position.23. The autoinjector according to claim 22, wherein when the carrier isin the second axial position, a boss of a compliant beam disengages anopening in the plunger and the plunger translates axially relative tothe carrier under a force of the drive spring advancing the carrier fromthe second axial position to a third axial position relative to thecase.
 24. The autoinjector according to claim 23, wherein the collarrotates to a third angular position relative to the case and translateswith the needle shroud distally relative to the case when the carrier isin the third axial position.
 25. The autoinjector according to claim 24,wherein the collar rotates to a fourth angular position relative to thecase when the needle shroud is in the locked second extended position.26. The autoinjector according to claim 25, wherein a shroud bossengages a shroud slot notch in a shroud slot and a carrier boss engagesa carrier slot notch in a carrier slot when the collar is in the fourthangular position and the needle shroud is in the locked second extendedposition.
 27. The autoinjector according to claim 26, wherein theengagement of the carrier boss and the carrier slot notch substantiallyfixes the collar in an axial position relative to the case.
 28. Theautoinjector according to claim 15, further comprising: a control springbiasing the collar relative to the case.
 29. The autoinjector accordingto claim 15, further comprising: a trigger button coupled to or integralwith the carrier.